Japan PMDA registration 341508_30300EZX00088000_A_01_01

FTD SARS-CoV-2 Kit

JP: FTD SARS-CoV-2キット
Japan flagJapan·IVD·IVD·Updated December 27, 2021
Intended use / 使用目的
English
SARS-CoV-2 in biological samples
日本語 (Japanese)
生体試料中のSARS-CoV-2
Device classification / 分類
Device Type
IVD
Device Class
IVD
Class Name (English)
SARS coronavirus nucleic acid kit
Class Name (日本語)
SARSコロナウイルス核酸キット
Registration information / 登録情報
PMDA ID
341508_30300EZX00088000_A_01_01
Last Update Date
December 27, 2021
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/シーメンスヘルスケア・ダイアグノスティクス株式会社
About this record

Access comprehensive regulatory information for FTD SARS-CoV-2 Kit (FTD SARS-CoV-2キット) in the Japan medical device market through Pure Global AI's free bilingual database. This IVD medical device is registered under PMDA ID 341508_30300EZX00088000_A_01_01 and manufactured by Manufacture and sales / Siemens Healthcare Diagnostics Co., Ltd.. The device information was last updated on December 27, 2021.

This page provides complete registration details including device class (IVD), classification (SARS coronavirus nucleic acid kit / SARSコロナウイルス核酸キット), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.

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